Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JAB-21822 · 8 trials · 15 indications
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC).
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
Mass balance recovery of total radioactivity in urine and fecal samples
Highest radioactivity observed plasma concentration
Area under the plasma concentration time curve
Elimination half-life
Mean residence time
Time for Cmax
Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
Area under the plasma concentration time curve of JAB-21822
Area under the plasma concentration time curve of JAB-21822
Highest observed plasma concentration of JAB-21822
RP2D should be selected based on a comprehensive assessment of maximum tolerated dose(MTD), toxicity, pharmacokinetic(PK) profile, and efficacy data.
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically significant abnormal laboratory value occurring in Cycle 1 (DLT assessment period), which is unrelated to progressive disease, concurrent disease, or concomitant medication but related to JAB-21822 and/or JAB-3312, and meets the criteria for DLT.
A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.
Number of participants with dose limiting toxicities
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1
| Arm | Type | Description |
|---|---|---|
| JAB-21822+JAB-3312 | EXPERIMENTAL | JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle |
| Tislelizumab combined with Pemetrexed + Carboplatin | ACTIVE_COMPARATOR | Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle |
| JAB-21822 | EXPERIMENTAL | Monotherapy |
| JAB-21822+Itraconazole | EXPERIMENTAL | - |
| JAB-21822+ Rifampicin | EXPERIMENTAL | - |
| JAB-21822+ Omeprazole | EXPERIMENTAL | - |
| Dazolam , Rosuvastatin calcium and digoxin with JAB-21822 | EXPERIMENTAL | - |
| [14C]JAB-21822 | EXPERIMENTAL | Single oral dose of 800mg 14C\]JAB-2182 suspension |
| A-JAB-21822 | EXPERIMENTAL | Dosing in the fasted state followed by fed dosing |
| B-JAB-21822 | EXPERIMENTAL | Dosing in the fed state followed by fasted dosing |
| Dose escalation | EXPERIMENTAL | - |
| Dose expansion | EXPERIMENTAL | - |
| Phase 1b Dose Escalation | EXPERIMENTAL | Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab. |
| Phase 2 Dose Expansion, Cohort 1 | EXPERIMENTAL | Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. |
| Phase 2 Dose Expansion, Cohort 2 | EXPERIMENTAL | Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer. |
| Phase 1 Dose Exploration | EXPERIMENTAL | Dose escalation of JAB-21822 to determine maximum tolerated dose. |
| Phase IIa Dose Expansion | EXPERIMENTAL | Patients with KRAS p.G12C mutant advanced non small cell lung cancer or other solid tumors will be enrolled and treated at the monotherapy RP2D to evaluate the safety and preliminary efficacy. |
| Phase IIb | EXPERIMENTAL | Patients with KRAS p.G12C mutant advanced non small cell lung cancer will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy. |
| Name | Type | Description |
|---|---|---|
| JAB-21822 | DRUG | JAB-21822 administered orally as a tablet |
| Tislelizumab | DRUG | Tislelizumab administered as an intravenous (IV) infusion |
| JAB-3312 | DRUG | JAB-3312 administered orally as a tablet or capsule |
| Pemetrexed | DRUG | Pemetrexed administered as an intravenous (IV) infusion |
| Carboplatin | DRUG | Carboplatin administered as an intravenous (IV) infusion |
| Itraconazole | DRUG | Itraconazole was administered orally |
| Omeprazole | DRUG | Omeprazole was administered orally |
| Midazolam , Rosuvastatin calcium and digoxin | DRUG | Midazolam , Rosuvastatin calcium and digoxin was administered orally |
| Rifampicin | DRUG | Rifampicin was administered orally |
| [14C]JAB-21822 | DRUG | Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach |
| Cetuximab | DRUG | Cetuximab administered as an intravenous (IV) infusion. |
Inclusion Criteria: * A signed written informed consent is required before performing any study-related operations * Age greater than or equal to 18 years old * Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirme...